American Pharmaceutical Ingredients LLC
Form 483 issued December 14, 2017 · Waterford, Michigan
- Inspection
- Nov 21 – Dec 11, 2017
- Investigators
- Emilie Kahn· Sarah E. Rhoades
- Observations
- 14
- Pages
- 14
- FEI number
- 3010302040
In short: On December 14, 2017, FDA issued a Form 483 with 14 observations to American Pharmaceutical Ingredients LLC in Waterford, Michigan (FEI 3010302040) after an inspection that ran Nov 21 – Dec 11, 2017. The investigators were Emilie Kahn and Sarah E. Rhoades. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 9 of 14 observations.
Most cited: 21 CFR 211.192 (3×) · 211.22 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The system for managing…
- 02
Supplier approval does not provide adequate evidence that manufacturers can consistently…
- 03
Contract laboratories are not evaluated…
- 04
Your quality system does not include a consistent organizational structure with activities necessary to ensure that…
This inspection in context
Emilie Kahn
15 documents · 2016–2019
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Michigan.
The firmAmerican Pharmaceutical Ingredients LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at American Pharmaceutical Ingredients LLC?
FDA listed 14 observations on this Form 483, mostly about quality system, laboratory controls and materials. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected American Pharmaceutical Ingredients LLC?
Emilie Kahn and Sarah E. Rhoades are named on this Form 483, for the inspection of Nov 21 – Dec 11, 2017. Each investigator has a profile showing what they cite most.
When was American Pharmaceutical Ingredients LLC inspected by FDA?
The inspection ran Nov 21 – Dec 11, 2017, and the Form 483 is dated December 14, 2017.
How do I get the full Form 483 for American Pharmaceutical Ingredients LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.