Bell-More Labs, Inc
FDA inspection history in Hampstead, Maryland, 2007 to 2024
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2007: one warning letter; 2015: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2007One warning letter, at Hampstead, Maryland.
- 2015One Form 483, at Hampstead, Maryland.
- 2024One Form 483, at Hampstead, Maryland.
- 2024The longest 483 on file: 11 observations over 18 pages at Hampstead, Maryland.
Cited most
Across all Bell-More Labs observations on file
- 21 CFR 211.42Design and construction features6
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.137Expiration dating1
- 21 CFR 211.192Production record review1
The complete Bell-More Labs 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
Hampstead, Maryland
Two Form 483s and one warning letter · 2007 to 2024 · 18 observations
Latest: Form 483, Apr 3, 2024 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-04-03 | 483 Form 483 | Hampstead, Maryland | 11 | $99 |
| 2015-03-13 | 483 Form 483 | Hampstead, Maryland | 7 | $99 |
| 2007-01-05 | Warning letter Warning letter | Hampstead, Maryland | — | $99 |
Investigators on these documents
Andrew O. Ejiofor (1)Edmund F. Mrak (1)Frederick Razzaghi (1)Rachel C. Harrington (1)Tajah L. Blackburn (1)Vipulchandr N. Dholakia (1)
FEI number 1150023 · most recent document Apr 3, 2024
About Bell-More Labs, Inc
How many FDA Form 483s has Bell-More Labs, Inc received?
FDA Intel has 2 Form 483s on file for Bell-More Labs, Inc; the most recent is dated Apr 3, 2024.
When was Bell-More Labs, Inc last inspected by FDA?
The most recent FDA inspection document on file for Bell-More Labs, Inc is a Form 483 dated Apr 3, 2024, for the site in Hampstead, Maryland.
What did FDA cite at Bell-More Labs, Inc?
The regulations cited most in the observations on file for Bell-More Labs, Inc are 21 CFR 211.42 (Design and construction features), 6 times; 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times.
Has Bell-More Labs, Inc received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Bell-More Labs, Inc; the most recent is dated Jan 5, 2007.