Bachem Americas, Inc.
Form 483 issued May 18, 2018 · Torrance, California
- Investigator
- Stephanie A. Slater
- Observations
- 6
- Pages
- 12
- FEI number
- 2024023
In short: On May 18, 2018, FDA issued a Form 483 with 6 observations to Bachem Americas, Inc. in Torrance, California (FEI 2024023). The investigator was Stephanie A. Slater. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and facilities & equipment account for 5 of 6 observations.
Most cited: 21 CFR 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
Your firm’s Quality Assurance (QA) did not review and approve quality system investigation documents in a…
- 02
Your firm did not follow the established written procedure titled, SOP-3-00429,(b) (4) . Product Reviews, Revision…
- 03
Your firm did not perform preventive maintenance (PM) of production equipment on time, per the written…
- 04
Your firm did not perform qualification audits of component and raw material suppliers and contract laboratories…
This inspection in context
Stephanie A. Slater
20 documents · 2015–2021
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in California.
The firmBachem Americas, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bachem Americas, Inc.?
FDA listed 6 observations on this Form 483, mostly about quality system, facilities & equipment and production. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Bachem Americas, Inc.?
Stephanie A. Slater is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Bachem Americas, Inc. inspected by FDA?
This Form 483 is dated May 18, 2018.
How do I get the full Form 483 for Bachem Americas, Inc.?
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.