Formology Lab Inc.
FDA inspection history across 2 sites, 2022 to 2023
- 1
- Warning letter
- 1
- Form 483
- 1
- Close-out
Every document, by year
- Warning letter
- Form 483
- Close-out
2022: one Form 483; 2023: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2022–23One Form 483 and one warning letter, at CHATSWORTH, California and Chatsworth, California.
Cited most
Across all Formology Lab observations on file
- 21 CFR 211.22(a)Responsibilities of quality control unit2
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.113(a)Control of microbiological contamination1
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.192Production record review1
The complete Formology Lab file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Chatsworth, California
One warning letter and one close-out letter · 2023
Latest: Warning letter, Mar 1, 2023 →CHATSWORTH, California
One Form 483 · 2022 · 8 observations
Latest: Form 483, Sep 9, 2022 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-03-01 | Warning letter Warning letter | Chatsworth, California | — | $99 |
| 2022-09-09 | 483 Form 483 | CHATSWORTH, California | 8 | $99 |
| Undated | Close-out Close-out letter | Chatsworth, California | — | $99 |
Investigators on these documents
FEI number 3014278936 · most recent document Mar 1, 2023
About Formology Lab Inc.
How many FDA Form 483s has Formology Lab Inc. received?
FDA Intel has 1 Form 483 on file for Formology Lab Inc.; the most recent is dated Sep 9, 2022.
When was Formology Lab Inc. last inspected by FDA?
The most recent FDA inspection document on file for Formology Lab Inc. is a Form 483 dated Sep 9, 2022, for the site in CHATSWORTH, California.
What did FDA cite at Formology Lab Inc.?
The regulations cited most in the observations on file for Formology Lab Inc. are 21 CFR 211.22(a) (Responsibilities of quality control unit), 2 times; 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.113(a) (Control of microbiological contamination), 1 time.
Has Formology Lab Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Formology Lab Inc.; the most recent is dated Mar 1, 2023.