Drug factory · FDA FEI 1000513636
Braintree Laboratories, Inc.
270 Centre Street, Holbrook, MA, United States
No problems found at FDA's last inspection, Mar 7, 2025.
No Action Indicated: inspectors found no objectionable conditions.
7 drug inspections on record since 2009: 3 with no problems, 3 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Magnesium Cation and Potassium Cation and Sodium Cation | Makes it and tests it | Affordable Pharmaceuticals, LLC, Braintree Laboratories, Inc. | 10572-012, 10572-112, 52268-012 +1 |
| Magnesium Cation and Potassium Cation and Sodium Sulfate | Makes it and tests it | Braintree Laboratories, Inc. | 52268-201 |
| Polyethylene Glycol 3350 and Potassium Cation and Sodium Cation | Makes it, tests it and labels it | Affordable Pharmaceuticals, LLC, Braintree Laboratories, Inc. | 10572-100, 10572-101, 10572-302 +3 |
| Polyethylene Glycol 3350, Sodium Sulfate, Potassium Chloride, Magnesium Sulfate, | Makes it and tests it | Braintree Laboratories, Inc. | 52268-550 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 7, 2025 | No problems found | Drug Quality Assurance | — |
| Feb 28, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Dec 13, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 14, 2013 | No problems found | Drug Quality Assurance | — |
| Jan 21, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | 7 |
| Jan 22, 2010 | Serious problems, FDA action | Drug Quality Assurance | — |
| May 13, 2009 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Feb 28, 2018 inspection
- Complaint Record required information 21 CFR 211.198(b)(1)
Complaint records are deficient in that they do not include the known reply to complainant. - Composite sample top/middle/bottom 21 CFR 211.84(c)(4)
Sampling procedures are deficient regarding compositing for testing of samples collected from the top, middle, and bottom of the component container.
Jan 21, 2011 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review whether or not the batch has been already distributed. - Approve or reject procedures or specs 21 CFR 211.22(c)
The quality control unit lacks responsibility to approve all procedures or specifications impacting on the identity, strength, quality, and purity of drug products. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration of electronic equipment is not performed according to a written program designed to assure proper performance. - Top/Middle/Bottom container sampling 21 CFR 211.84(c)(4)
Sampling procedures are deficient regarding sampling components from the top, middle, and bottom of container. - Component written specification 21 CFR 211.84(d)(2)
Component testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
Registered with FDA for: analysis; label; manufacture; pack.