Formology Lab Inc.
Form 483 issued September 9, 2022 · CHATSWORTH, California
- Inspection
- Aug 30 – Sep 9, 2022
- Investigators
- Crystal Monroy· Lillian S. Wu
- Observations
- 8
- Pages
- 9
- FEI number
- 3014278936
In short: On September 9, 2022, FDA issued a Form 483 with 8 observations to Formology Lab Inc. in CHATSWORTH, California (FEI 3014278936) after an inspection that ran Aug 30 – Sep 9, 2022. The investigators were Crystal Monroy and Lillian S. Wu. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and production account for 5 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review the failure of a batch or any of its…
- 02
The quality control unit lacks the responsibility and authority to approve and reject all components, drug…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
- 04
There is no written testing program designed to assess the stability…
This inspection in context
Crystal Monroy
15 documents · 2014–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmFormology Lab 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Formology Lab Inc.?
FDA listed 8 observations on this Form 483, mostly about quality system, production and facilities & equipment. 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 Formology Lab Inc.?
Crystal Monroy and Lillian S. Wu are named on this Form 483, for the inspection of Aug 30 – Sep 9, 2022. Each investigator has a profile showing what they cite most.
When was Formology Lab Inc. inspected by FDA?
The inspection ran Aug 30 – Sep 9, 2022, and the Form 483 is dated September 9, 2022.
How do I get the full Form 483 for Formology Lab 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.