Atlas

Form 483

Amphastar Pharmaceuticals, Inc. Form 483, 2017-03-31

FDA issued a Form 483 to Amphastar Pharmaceuticals, Inc. on 2017-03-31 with 100 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health100 observations

Amphastar Pharmaceuticals, Inc. · Rancho Cucamonga, United States · Issued March 31, 2017

Overview

  • 100 public-safe observations are available for this inspection.
  • 18 structured CFR citations are represented.
  • 9 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

31 Mar 2017
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Jeffrey P Raimondi, Sonya L Karsik, Carrie A Hughes, Marcus F Yambot, Amanda L Fyles, Walden H Lee, Amir Alavi, Jennifer M Gogley, Xiaohui Shen

31 Mar 2017
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Jeffrey P Raimondi, Sonya L Karsik, Carrie A Hughes, Marcus F Yambot, Amanda L Fyles, Walden H Lee, Amir Alavi, Jennifer M Gogley, Xiaohui Shen

31 Mar 2017
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Jeffrey P Raimondi, Sonya L Karsik, Carrie A Hughes, Marcus F Yambot, Amanda L Fyles, Walden H Lee, Amir Alavi, Jennifer M Gogley, Xiaohui Shen

31 Mar 2017
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Jeffrey P Raimondi, Sonya L Karsik, Carrie A Hughes, Marcus F Yambot, Amanda L Fyles, Walden H Lee, Amir Alavi, Jennifer M Gogley, Xiaohui Shen

31 Mar 2017
21 CFR 211.113(b)

Validation lacking for sterile drug products

Cited by Jeffrey P Raimondi, Sonya L Karsik, Carrie A Hughes, Marcus F Yambot, Amanda L Fyles, Walden H Lee, Amir Alavi, Jennifer M Gogley, Xiaohui Shen

Inspected site

APAmphastar Pharmaceuticals, Inc.Rancho Cucamonga, United States

Inspection team

JPJeffrey P Raimondi
SLSonya L Karsik
CACarrie A Hughes
MFMarcus F Yambot
ALAmanda L Fyles
WHWalden H Lee
AAAmir Alavi
JMJennifer M Gogley
XSXiaohui Shen

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.113(b)Cited across public-safe Form 483 observations10x
21 CFR 820.30(g)Cited across public-safe Form 483 observations10x
21 CFR 211.100(b)Cited across public-safe Form 483 observations5x
21 CFR 211.165(e)Cited across public-safe Form 483 observations5x
21 CFR 211.180(b)Cited across public-safe Form 483 observations5x
21 CFR 211.188Cited across public-safe Form 483 observations5x
21 CFR 211.192Cited across public-safe Form 483 observations5x
21 CFR 211.22(d)Cited across public-safe Form 483 observations5x
21 CFR 211.63Cited across public-safe Form 483 observations5x
21 CFR 211.67(a)Cited across public-safe Form 483 observations5x
21 CFR 211.68(b)Cited across public-safe Form 483 observations5x
21 CFR 211.80(a)Cited across public-safe Form 483 observations5x
21 CFR 820.100(a)Cited across public-safe Form 483 observations5x
21 CFR 820.30(b)Cited across public-safe Form 483 observations5x
21 CFR 820.30(c)Cited across public-safe Form 483 observations5x
21 CFR 820.30(d)Cited across public-safe Form 483 observations5x
21 CFR 820.30(f)Cited across public-safe Form 483 observations5x
21 CFR 820.50Cited across public-safe Form 483 observations5x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Book a demoStart a free trial

Full 483 report

Get the verbatim text of all 100 observations

The source PDF and every observation in full, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere