Hetero Labs FDA inspection history: every unit, every 483, and where things stand

FDA has inspected Hetero's facilities 54 times since 2007, and 34 of those inspections ended with a Form 483. The one warning letter, to Unit V at Jadcherla in 2017, was closed out in 2022. The Vemagal facility in Karnataka passed its January 2025 inspection clean. The latest recorded inspections, in September 2025 at Unit IX and at Chinateenarla, both ended with a 483.

Those counts come from the Atlas facility records (release of August 15, 2026), which hold 15 Hetero site records across India and the US. Below is what FDA found at each facility, which regulations it keeps citing, and how the unit numbers people search for map to FDA's records.

Hetero's facilities in FDA's records

FDA records each facility under an FEI number and an address, not under the company's unit numbers. Where a primary document ties a unit to an FEI, we say so in the table. The other rows use the city FDA records.

Seven smaller records make up the rest: Hetero USA in Piscataway, New Jersey (2 inspections, both 483s), Bodugallam (2, one 483), Hetero Drugs in Medak District (2, one 483), and four records with only clean inspections (Hetero Drugs in Hyderabad and Visakhapatnam, Hetero Labs in Sanath Nagar, and a 2007 record named "Hetero Drugs Limited, Unit-III (Formulations)"). All 15 records, with every inspection, are in our FDA-inspected sites directory.

How the unit labels are sourced:

• Unit V. FDA's 2017 warning letter names Hetero Labs Limited Unit V at Polepally Village, Jadcherla Mandal, with FEI 3008307735.
• Unit 3. A WHO prequalification report on Hetero Labs Unit 3 (Survey No. 51, Plot 22-110, IDA Jeedimetla, Hyderabad) reviewed the FDA inspection of May 30 and June 3 to 7, 2019. The only Hetero record in Atlas inspected on those dates is the Hyderabad record, FEI 3005406526.
• Unit I. The WHO report on Unit I (Survey No. 10, IDA Gaddapotharam, Jinnaram Mandal, Sangareddy) lists an FDA inspection from August 2 to 12, 2021, classified OAI. Atlas has the same dates on the Sangareddy record, FEI 3004378446.

The other Mahaboob Nagar record (FEI 3008294355) has no unit label in FDA's data. Its citations for sterile drug validation and aseptic area controls point to sterile manufacturing, so we label it by city only.

What FDA cited on Hetero's Form 483s

Atlas holds 15 Hetero Form 483s with observation detail, issued between 2009 and 2023, carrying 75 observations. The largest were 12 observations at Mahaboob Nagar in May 2013, 11 at Unit 3 in June 2019, and 8 at Mahaboob Nagar in September 2023.

Nine further forms are in Atlas but not shown above: Unit 3 in 2009 (5 observations), 2011 (4), 2013 (1), 2016 (6) and March and October 2018 (6 each), Unit V in April 2019 (3), and Hetero USA in 2011 (1) and 2017 (3, on postmarketing safety reporting under 21 CFR 314.80).

Counting each section once per form, the pattern is clear:

Investigations under 211.192 appear on Hetero forms in 2009, 2011, 2016, 2019 and twice in 2023, at both Unit 3 and Mahaboob Nagar. Unit 3's record alone shows six 211.192 observations. FDA keeps finding that out-of-specification results and deviations were not investigated far enough. Our guide to OOS results and how FDA reads them covers what a complete investigation needs.

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The 2017 warning letter at Unit V, and its closeout

FDA inspected Unit V at Jadcherla from December 7 to 16, 2016 and issued Warning Letter 320-17-46 on August 15, 2017. It cited three violations:

1. 21 CFR 211.192: investigations of process deviations and out-of-specification results, including a dissolution failure on a contract-manufactured tablet lot, lacked scientifically supported conclusions.
2. 21 CFR 211.67(a): equipment identified as clean had colored residue or was in poor repair.
3. 21 CFR 211.22(d): the quality unit did not follow its recall procedure for a failing finasteride lot, and the recall did not start until December 23, 2016.

FDA also warned that it could withhold approval of new applications listing the facility and refuse admission of its products until the violations were corrected.

FDA issued a closeout letter on November 29, 2022, stating that Hetero appeared to have addressed the violations. The Atlas record shows how that sat alongside inspections: FDA was back at Unit V in April 2019 (3 observations) and again in August 2022, three months before the closeout. The August 2022 form cited 211.22(d) and equipment cleaning procedures under 211.67(b), the same two areas the 2017 letter covered. A closeout does not mean later inspections are clean, a point our piece on the 483 versus the warning letter covers in more detail.

We found no other warning letter to a Hetero facility on FDA's warning letter pages.

Vemagal, Karnataka: one observation, then a clean inspection

The Vemagal facility in Kolar District is the newest Hetero site in FDA's records (FEI 3022837118). Hetero acquired the facility from GSK Pharmaceuticals, whose board approved the sale for Rs 180 crore in April 2021, as reported by PTI at the time.

FDA has inspected it twice:

That is a light record: a single equipment cleaning observation, followed by an NAI inspection 20 months later. If you are qualifying Vemagal as a supplier, the 2023 form and the 2025 outcome are both on its facility page. The NAI, VAI and OAI guide explains what each classification means for future inspections.

The latest status: September 2025 at Unit IX and Chinateenarla

The most recent Hetero inspections in Atlas both ran from September 19 to 26, 2025, and both ended with a Form 483:

• Unit IX in Visakhapatnam (FEI 3009093782), now on its fifth straight 483 after inspections in 2014, 2017, 2019, 2022 and 2025.
• A new record at Chinateenarla (FEI 3040501127), inspected for the first time, by Guerlain Ulysse and Constance L Richard Math.

Medical Dialogues reported in October 2025 that FDA issued a 483 after a September 19 to 26 inspection of Hetero's Nakkapalli facility in Andhra Pradesh. The reported findings include finished APIs meant for the US released to an off-site warehouse without proper documentation, and testing at an unregistered laboratory outside the registered premises whose out-of-specification results were not recorded. The dates match the two Atlas records above. FDA has not posted a warning letter for either facility.

Earlier in 2025, Hetero Drugs at Gummadidala received a 483 after a May 12 to 16 inspection, its fourth 483 in seven inspections. Unit I's last inspection, September 4 to 8, 2023, also ended with a 483, two years after the 2021 inspection that WHO records as OAI.

Of the nine Hetero inspections since January 2023, seven ended with a 483. Atlas has no Hetero inspection dated 2026 in this release. Investigator Guerlain Ulysse has now inspected three Hetero facilities: Hetero USA in 2017, Unit V in 2022 and Chinateenarla in 2025. For the wider context, see the India human drugs inspection trends and our piece on how FDA's overseas inspections changed in 2024 and 2025.

What Indian quality teams can take from Hetero's record

Repeat citations get read across sites. 211.192 has appeared at two Hetero facilities across 14 years. When an investigator sees the same section on a company's earlier forms, the next form is written with that history in mind.

The closeout is a floor. Unit V's warning letter was closed in 2022, yet the August 2022 form cited the same quality unit and cleaning areas. Treat a closeout as the start of the sustainability check FDA's letter describes.

Off-site operations are inspected. The reported Nakkapalli findings concern a warehouse and a laboratory outside the registered premises. Every location that stores or tests US product needs to be in your registration and under your quality system.

Supplier files need FEI-level detail. If you buy API or finished dosage from Hetero, the unit matters. Vemagal's record and Unit IX's record would lead to different risk ratings.

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