Brooke K. Higgins
FDA investigator
Appears on 5 documents from 2011 to 2014, most often at sites in Maryland. Most often cites design and construction features (21 CFR 211.42(c)(10)).
- 5
- Documents on file
- 6.0
- Observations per 483
- 2011
- First seen
- 2014
- Most recent
What they cite most
From 30 observations- 21 CFR 211.42(c)(10)Design and construction features8
- 21 CFR 211.113Control of microbiological contamination5
- 21 CFR 211.100(a)Written procedures; deviations2
- 21 CFR 211.28(a)Personnel responsibilities2
- 21 CFR 211.111Time limitations on production1
- 21 CFR 211.160(b)General requirements1
Activity by year
2011: 1, 2012: 1, 2013: 1, 2014: 2
Where
Maryland 2 · Virginia 2 · Florida 1
Often inspects with
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Inspection history
5 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2014-04-09 | 483 Bora Pharmaceuticals Injectables Inc.Apr 9, 2014 · Baltimore, Maryland | Baltimore, Maryland | 1 | |
| 2014-02-21 | 483 RX South LLC DBA RX3 PharmacyFeb 21, 2014 · Chester, Virginia | Chester, Virginia | 11 | |
| 2013-03-21 | 483 Lowlite Investments, Inc. (dba Olympia Pharmacy)Mar 21, 2013 · Orlando, Florida | Orlando, Florida | 12 | |
| 2012-08-24 | 483 Merck Sharp & Dohme LLCAug 24, 2012 · Elkton, Virginia | Elkton, Virginia | 2 | |
| 2011-07-22 | 483 Bora Pharmaceuticals Injectables Inc.Jul 22, 2011 · Baltimore, Maryland | Baltimore, Maryland | 4 |
About this profile
What does Brooke K. Higgins inspect?
Brooke K. Higgins appears on 5 documents on file covering 4 sites, most often in Maryland.
What do they cite most often?
21 CFR 211.42(c)(10) (design and construction features), followed by 21 CFR 211.113 and 21 CFR 211.100(a).
Can I read the observations?
Each document page previews the opening words of every observation. The full documents are available to buy, one at a time or together.
How current is this profile?
The most recent document on file for Brooke K. Higgins is dated Apr 9, 2014.