Drug factory · FDA FEI 3002936358

Amphastar Pharmaceuticals, Inc.

11570 6th Street, Rancho Cucamonga, CA, United States

What it does, for whom

FDA inspection history

What inspectors wrote down

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Feb 6, 2013 inspection

• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
• Actual yield, % of theoretical yield 21 CFR 211.188(b)(7)
  The batch production and control records do not include a statement of the actual yield and percentage of theoretical yield at appropriate stages of processing for each batch of drug product produced.
• Establish reliability of supplier's C of A 21 CFR 211.84(d)(2)
  Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.

Jun 28, 2012 inspection

• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
• Training--operations, GMPs, written procedures 21 CFR 211.25(a)
  Employees are not given training in the particular operations they perform as part of their function.
• Training--operations, GMPs, written procedures 21 CFR 211.25(a)
  Employees are not given training in the particular operations they perform as part of their function.
• Failure to submit ADE report 21 CFR 310.305(c)
  Adverse drug experience information has not been reported to FDA.
• Failure to submit ADE report 21 CFR 310.305(c)
  Adverse drug experience information has not been reported to FDA.
• Late submission of 15-day report 21 CFR 314.80(c)(1)(i)
  Not all adverse drug experiences that are both serious and unexpected have been reported to FDA within 15 calendar days of initial receipt of the information.
• Late submission of 15-day report 21 CFR 314.80(c)(1)(i)
  Not all adverse drug experiences that are both serious and unexpected have been reported to FDA within 15 calendar days of initial receipt of the information.
• Failure to meet specifications 21 CFR 314.81(b)(1)(ii)
  An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning a failure of one or more distributed batches of a drug to meet the specifications established for it in the application.
• Failure to meet specifications 21 CFR 314.81(b)(1)(ii)
  An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning a failure of one or more distributed batches of a drug to meet the specifications established for it in the application.
• Mfg and control changes not requiring a supplemental app. 21 CFR 314.81(b)(2)(iv)(b)
  An annual report did not include a full description of the manufacturing and control changes not requiring a supplemental application, listed by date in the order in which they were implemented.
• Mfg and control changes not requiring a supplemental app. 21 CFR 314.81(b)(2)(iv)(b)
  An annual report did not include a full description of the manufacturing and control changes not requiring a supplemental application, listed by date in the order in which they were implemented.

Aug 19, 2009 inspection

• Items to cover on annual reviews 21 CFR 211.180(e)(2)
  Written procedures are not followed for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products, and investigations conducted for each drug product.
• Items to cover on annual reviews 21 CFR 211.180(e)(2)
  Written procedures are not followed for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products, and investigations conducted for each drug product.
• Records of disposition of rejected material 21 CFR 211.184(e)
  Records do not include the disposition of rejected components, drug product containers, closures, and labeling.
• Records of disposition of rejected material 21 CFR 211.184(e)
  Records do not include the disposition of rejected components, drug product containers, closures, and labeling.

Registered with FDA for: analysis; distribute; label; manufacture; pack.