Libby Laboratories, Inc.
Form 483 issued March 14, 2025 · Berkeley, California
- Investigators
- Anney Lin· Nathan E. Hellman
- Observations
- 2
- Pages
- 4
- FEI number
- 2912388
In short: On March 14, 2025, FDA issued a Form 483 with 2 observations to Libby Laboratories, Inc. in Berkeley, California (FEI 2912388). The investigators were Anney Lin and Nathan E. Hellman. Most observations concern materials and laboratory controls; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Materials and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.84(a) (1×) · 211.165(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Each lot of components is not withheld from use until the lot has been sampled, tested…
- 02
Each batch of drug product required to be free of objectionable microorganisms is not tested…
This inspection in context
Anney Lin
9 documents · 2023–2026
Cites 211.84 (testing and approval or rejection of components, drug product containers, and closures) more than any other section. Most of their documents are for sites in California.
The firmLibby Laboratories, 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 211.84(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Libby Laboratories, Inc.?
FDA listed 2 observations on this Form 483, mostly about materials and laboratory controls. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Libby Laboratories, Inc.?
Anney Lin and Nathan E. Hellman are named on this Form 483. Each investigator has a profile showing what they cite most.
When was Libby Laboratories, Inc. inspected by FDA?
This Form 483 is dated March 14, 2025.
How do I get the full Form 483 for Libby Laboratories, 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.