Drug factory · FDA FEI 1221426
Boston Analytical Inc dba BA Sciences
14 Manor Parkway, Salem, NH, United States
No problems found at FDA's last inspection, Mar 7, 2023.
No Action Indicated: inspectors found no objectionable conditions.
7 drug inspections on record since 2009: 1 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Irinotecan | Tests it | Ipsen Biopharmaceuticals, Inc. | 15054-0043 |
| Tolvaptan | Tests it | Otsuka America Pharmaceutical, Inc. | 59148-079, 59148-080, 59148-082 +4 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 7, 2023 | No problems found | Drug Quality Assurance | — |
| Jan 24, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Sep 22, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Jun 23, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Nov 9, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 16, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 23, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jan 24, 2020 inspection
- Sampling and testing plans not followed 21 CFR 211.165(c)
Written procedures for sampling and testing plans are not followed for each drug product.
Sep 22, 2016 inspection
- Written program not followed 21 CFR 211.166(a)
The written stability testing program is not followed. - Laboratory Test Method Verification 21 CFR 211.194(a)(2)
Verification of the suitability of the testing methods is deficient in that they are not performed under actual conditions of use.
Jun 23, 2015 inspection
- Personnel dating/signing equipment log 21 CFR 211.182
The persons double-checking the cleaning and maintenance are not dating and signing or initialing the equipment cleaning and use log. - Test method modification records do not include 21 CFR 211.194(b)
Records maintained of any modification of an established method employed in testing do not include the reason for the modification . - Complaint Handling Procedure 21 CFR 211.198(a)
Procedures describing the handling of written and oral complaints related to drug products are not written or followed . - Written procedures fail to include 21 CFR 211.67(b)
Written procedures for cleaning and maintenance fail to include description in sufficient detail of the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance .
Dec 23, 2009 inspection
- Following/documenting laboratory controls 21 CFR 211.160(a)
Established standards are not followed. - Instruments, apparatus, et. al. not meeting specs 21 CFR 211.160(b)(4)
The use of instruments and apparatus not meeting established specifications was observed. - Failing drug products not rejected 21 CFR 211.165(f)
Drug products failing to meet established specifications are not rejected. - Complete Test Data 21 CFR 211.194(a)(4)
Laboratory records are deficient in that they do not include a complete record of all data obtained during testing. - Stability testing records not included 21 CFR 211.194(e)
Laboratory records do not include complete records of all stability testing performed.
Registered with FDA for: analysis.