Bachem Americas, Inc.
Form 483 issued February 10, 2017 · Vista, California
- Inspection
- Feb 7 – Feb 10, 2017
- Investigators
- Santos E. Camara· Walden H. Lee
- Observations
- 2
- Pages
- 2
- FEI number
- 3000718309
In short: On February 10, 2017, FDA issued a Form 483 with 2 observations to Bachem Americas, Inc. in Vista, California (FEI 3000718309) after an inspection that ran Feb 7 – Feb 10, 2017. The investigators were Santos E. Camara and Walden H. Lee. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
2 of 2 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68 (1×) · 211.48 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
The plumbing system contains defects that could contribute to the…
This inspection in context
Santos E. Camara
33 documents · 2015–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmBachem Americas, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bachem Americas, Inc.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Bachem Americas, Inc.?
Santos E. Camara and Walden H. Lee are named on this Form 483, for the inspection of Feb 7 – Feb 10, 2017. Each investigator has a profile showing what they cite most.
When was Bachem Americas, Inc. inspected by FDA?
The inspection ran Feb 7 – Feb 10, 2017, and the Form 483 is dated February 10, 2017.
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.