Bachem FDA inspection history: Torrance, Vista and every Form 483

Bachem's FDA inspection history is the public record of 37 FDA inspections at four Bachem facility records, two in California and two in Switzerland, 16 of which ended with a Form 483. The two US peptide API facilities carry most of it: Bachem Americas in Torrance has 18 inspections and 8 Form 483s, and Bachem Americas in Vista has 7 inspections and 4 Form 483s. Both closed inspections with a Form 483 in May 2026, and FDA classified both as Voluntary Action Indicated (VAI).

The counts come from Atlas facility records (release of August 15, 2026) and the 2026 classifications from FDA inspection classification data pulled in October 2026. This page covers each Bachem facility, the 2026 inspections, what the one Bachem Form 483 with public observation detail cites, which investigators know the facilities, and what to ask Bachem for if it makes your API.

Key facts:

• FDA inspected four Bachem facility records 37 times between 2001 and May 2026, and 16 of those inspections ended with a Form 483 (Atlas, release of August 15, 2026).
• Torrance (FEI 2024023) received a Form 483 at six of the seven inspections Atlas records from January 2012 to December 2019.
• FDA classified the April 27 to May 4, 2026 Torrance inspection as VAI on June 30, 2026, and the May 13 to 20, 2026 Vista inspection as VAI on July 22, 2026.
• The February 10, 2017 Vista Form 483 cites 21 CFR 211.48(a) on plumbing and 21 CFR 211.68(b) on computer control of master formula records.
• No Bachem entity appears among the 3,768 FDA warning letters issued from January 2021 to October 14, 2026 in the dataset Atlas holds.

Which Bachem facilities does FDA inspect?

FDA inspects four Bachem facility records, each filed under its own FEI number: Bachem Americas in Torrance and Vista, California, Bachem AG in Bubendorf and Bachem SA in Vionnaz, Switzerland. An FEI number is the identifier FDA assigns to each physical facility, and our guide to the FEI number explains how to find one. All four records are searchable in the Atlas FDA-inspected sites directory.

Bachem describes itself as a manufacturer of peptides and oligonucleotides and lists six locations: Bubendorf, Vionnaz and Sisslerfeld in Switzerland, St. Helens in the UK, and Torrance and Vista. Atlas holds no FDA inspection record for St. Helens or Sisslerfeld. A search for "Bachem" also returns Balchem and Chem Bac Labs, which are unrelated companies and are left out of every count here.

What is the FDA inspection record at Bachem Torrance?

Bachem Americas in Torrance has 18 FDA inspections on record from 2001 to May 2026, and 8 of them ended with a Form 483. Bachem's site page says the facility was founded in 1971, joined the group in 1996 and makes peptide APIs at small-to-medium scale, in the tens of kilograms a year.

The record splits into three periods. The first seven inspections, from 2001 to 2011, were clean, and Atlas holds no product category for them. From January 2012 to December 2019, six of the seven inspections ended with a Form 483: January 2012, November 2014, February 2016, May 2018, June 2019 and December 2019. Only the January 2013 visit was clean in that stretch.

The third period starts with two clean human drug inspections, in February 2022 and June 2024. In October 2024 FDA issued a Form 483 on an inspection filed under Animal Drugs and Feeds rather than human drugs. The latest inspection ran from April 27 to May 4, 2026, ended with a Form 483, and FDA classified it VAI in a letter dated June 30, 2026 (inspection ID 1315898). FDA's classification data lists no posted citations for it, so the sections on that form are not public yet.

Atlas ties 26 FDA investigators to the Torrance record. Virgilio F Pacio appears on three Torrance inspections, more than anyone else; Atlas puts him at 128 inspections and 371 Form 483 observations, with his latest activity in September 2016, so his Torrance visits predate 2017.

What is the FDA inspection record at Bachem Vista?

Bachem Americas in Vista has 7 FDA inspections on record from 2010 to May 2026, and 4 of them ended with a Form 483. Bachem acquired the facility in 2015 with American Peptide Company, and its site page describes Vista as the group's medium-to-large scale US facility for commercial peptide APIs, in the hundreds of kilograms a year. The 2010 and 2011 inspections predate Bachem's ownership.

The February 10, 2017 form is the only Bachem Form 483 with observation detail in Atlas. Walden H Lee and Santos E Camara wrote it, citing 21 CFR 211.48(a) on plumbing systems and 21 CFR 211.68(b) on computer control of master formula records. Lee has 92 inspections and 505 observations on record in Atlas and also appears on one Torrance inspection.

The Vista record also shows how FDA codes observations at an API facility. FDA judges API manufacturers against ICH Q7 under the FD&C Act, not under Part 211, yet investigators code API observations to the nearest Part 211 section, as our analysis of API manufacturer 483s found across 47 API Form 483s from 2025 and 2026. A 211.68(b) citation at a peptide API facility points to master records held in a computerized system.

Two investigators link the US facilities. Navneet Kaur and Linda Thai each appear on one Torrance and one Vista inspection. Kaur has 19 inspections on record with her latest activity in May 2026, and Thai has 179 inspections with her latest in June 2026.

If Bachem makes an API you file against, the investigators above are the ones who have seen these facilities, and their citation history at other sites shows what they check.

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What happened at the Bachem inspections in May 2026?

FDA inspected both Bachem US facilities in May 2026, and both inspections ended with a Form 483 and a VAI classification. Torrance closed on May 4 and was classified on June 30, 57 days later. Vista closed on May 20 and was classified on July 22, 63 days later. VAI means FDA found objectionable conditions but will not take or recommend regulatory action; our explainer on NAI, VAI and OAI covers each outcome.

The observations on the two 2026 forms are not public. FDA's classification data shows no posted citations for either inspection, and the Atlas release of August 15, 2026 holds the inspections but not their observation text. We found no Bachem announcement about either inspection as of November 7, 2026. The two VAI outcomes are the extent of what the public record says.

Bachem announced on October 23, 2025 that it plans to invest around USD 250 million in the United States from 2026 to 2030 to expand capacity in Vista and modernize the Torrance facility. New capacity at an existing FDA-inspected facility can bring a pre-approval inspection when an application names it, so the 2026 VAI outcomes are the baseline any later inspection will be read against.

What has FDA cited at the Swiss Bachem facilities?

FDA has issued four Form 483s across the two Swiss records, and none since September 2018. Bubendorf, Bachem's headquarters facility, has 8 inspections from 2001 to August 2024 and one Form 483, from March 2008. The four human drug inspections since 2014, the latest from August 12 to 16, 2024, were all clean.

Vionnaz has 4 inspections and 3 Form 483s: April 2010, June to July 2016 and September 2018. Its 2006 inspection was clean. Neither Swiss record holds observation detail in Atlas, and neither has an FDA inspection after 2024. FDA's approach to inspections outside the US, including short-notice visits, is covered in our post on FDA foreign inspections.

What should a supplier file on Bachem hold?

A supplier file on a Bachem facility should hold the latest Form 483, Bachem's response and the EIR for the facility that makes your material. The four records behave differently: Bubendorf has been clean on every inspection since 2008, while Torrance and Vista each received a Form 483 in May 2026.

For a Torrance or Vista API, ask Bachem for the May 2026 Form 483, its response and, once FDA sends it, the Establishment Inspection Report. Our guide to the EIR covers what the report contains. Then check whether the 2026 observations repeat the 2017 Vista themes of facility systems and computerized master records. A repeat citation across inspections weighs more in supplier qualification than a single observation.

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