Helen B. Ricalde
FDA investigator
Appears on 9 documents from 2003 to 2023, mostly at sites in New York. Most often cites design and construction features (21 CFR 211.42).
- 9
- Documents on file
- 4.7
- Observations per 483
- 2003
- First seen
- 2023
- Most recent
What they cite most
From 41 observations- 21 CFR 211.42Design and construction features6
- 21 CFR 211.67Equipment cleaning and maintenance4
- 21 CFR 1271.55What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain?3
- 21 CFR 211.100(a)Written procedures; deviations2
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.137(a)Expiration dating2
Activity by year
2003: 1, 2006: 1, 2014: 1, 2016: 3, 2018: 2, 2023: 1
Where
New York 5 · New Jersey 3 · Virginia 1
Often inspects with
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Inspection history
9 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2023-06-16 | 483 CELGENE CORPORATIONJun 16, 2023 · SUMMIT, New Jersey | SUMMIT, New Jersey | 4 | |
| 2018-07-10 | 483 Hunter Holmes McGuire Veterans Affairs Medical CenterJul 10, 2018 · Richmond, Virginia | Richmond, Virginia | 1 | |
| 2018-02-28 | 483 Chartwell Pharmaceuticals Carmel, LLCFeb 28, 2018 · Carmel, New York | Carmel, New York | 2 | |
| 2016-12-21 | 483 Form 483 · FEI 3008189622Dec 21, 2016 · Tuckahoe, New York | Tuckahoe, New York | 13 | |
| 2016-07-15 | 483 Hi-Tech Pharmacal, an AKORN CompanyJul 15, 2016 · Amityville, New York | Amityville, New York | 1 | |
| 2016-04-21 | 483 Asept Pak IncApr 21, 2016 · Malone, New York | Malone, New York | 4 | |
| 2014-08-22 | 483 Sina LLC, dba OncoMed (Onco 360)Aug 22, 2014 · Great Neck, New York | Great Neck, New York | 9 |
About this profile
What does Helen B. Ricalde inspect?
Helen B. Ricalde appears on 9 documents on file covering 8 sites, mostly in New York.
What do they cite most often?
21 CFR 211.42 (design and construction features), followed by 21 CFR 211.67 and 21 CFR 1271.55.
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 Helen B. Ricalde is dated Jun 16, 2023.