Drug factory · FDA FEI 1628936
Blessings International
1650 N Indianwood Ave, Broken Arrow, OK, United States
Problems found, fixed voluntarily at FDA's last inspection, May 14, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2010: 1 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Doxycycline | Makes it | Blessings International | 51376-780 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 14, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Jan 15, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Jul 9, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Dec 15, 2010 | 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.
May 14, 2026 inspection
- Storage under appropriate conditions 21 CFR 211.142(b)
Drug products are not stored under appropriate conditions of temperature and humidity so that their identity, strength, quality, and purity are not affected. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration of automatic and electronic equipment is not performed according to a written program designed to assure proper performance.
Jan 15, 2016 inspection
- Destruction of excess labels with lot numbers 21 CFR 211.125(d)
Excess labeling bearing lot or control numbers is not destroyed. - Description of containers, labels, et. al. 21 CFR 211.186(b)(8)
Master production and control records lack a specimen or copy of each label and all other labeling and the signatures and dates entered by the person or persons responsible for the approval of labeling . - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration of automatic , mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.
Jul 9, 2013 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. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. - Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
Registered with FDA for: relabel; repack.