LNK International, Inc.
FDA inspection history in Hauppauge, New York, 2017 to 2022
- 4
- Form 483s
- 2
- Close-outs
Every document, by year
- Form 483
- Close-out
2017: one Form 483; 2019: one close-out letter and one Form 483; 2021: one close-out letter and one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–22Four Form 483s and two close-out letters, at Hauppauge, New York.
- 2021The longest 483 on file: 5 observations over 6 pages at Hauppauge, New York.
Cited most
Across all LNK International observations on file
- 21 CFR 211.160(b)General requirements2
- 21 CFR 211.198(a)Complaint files2
- 21 CFR 211.192Production record review1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
- 21 CFR 211.25(a)Personnel qualifications1
The complete LNK International file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Hauppauge, New York
Four Form 483s and two close-out letters · 2017 to 2022 · 11 observations
Latest: Form 483, Dec 13, 2022 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-12-13 | 483 Form 483 | Hauppauge, New York | 1 | $99 |
| 2021-12-01 | Close-out Close-out letter | Hauppauge, New York | — | $99 |
| 2021-07-01 | 483 Form 483 | Hauppauge, New York | 5 | $99 |
| 2019-09-26 | Close-out Close-out letter | Hauppauge, New York | — | $99 |
| 2019-02-08 | 483 Form 483 | Hauppauge, New York | 3 | $99 |
| 2017-03-07 | 483 Form 483 | Hauppauge, New York | 2 | $99 |
Investigators on these documents
Bijoy Panicker (1)Brandy N. Lepage (1)Gam S. Zamil (1)Guerlain Ulysse (1)Sony Mathews (1)Terry Bridgewater (1)
FEI number 2432212 · most recent document Dec 13, 2022
About LNK International, Inc.
How many FDA Form 483s has LNK International, Inc. received?
FDA Intel has 4 Form 483s on file for LNK International, Inc.; the most recent is dated Dec 13, 2022.
When was LNK International, Inc. last inspected by FDA?
The most recent FDA inspection document on file for LNK International, Inc. is a Form 483 dated Dec 13, 2022, for the site in Hauppauge, New York.
What did FDA cite at LNK International, Inc.?
The regulations cited most in the observations on file for LNK International, Inc. are 21 CFR 211.160(b) (General requirements), 2 times; 21 CFR 211.198(a) (Complaint files), 2 times; 21 CFR 211.192 (Production record review), 1 time.